Skip to : [Content] [Navigation]
 
More CDRH Releases

Guidance Documents

Other FDA Documents

CDRH Resources

Current FDA Warning Letter Database

Archived FDA Warning Letter Database

Releasable 510(k)s

Releasable PMAs

Releasable Establishment Registrations

Releasable Device Listings

Good Guidance Practices

More CDRH databases

More FDA Articles

Medical Device & Diagnostic Industry

In Vitro Diagnostic Technology

Pharmaceutical & Medical Packaging News

 

FDA Federal Register Notices - Archives

2005 | 2004 | 2003 | 2002 | 2001

FDA Federal Register Notices - 2006 Releases
Federal Register: Medical Devices; Exemptions from Premarket Notification; Class II Devices (Notice)
 December 26, 2006
Federal Register: Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
 December 26, 2006
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Availability
 December 22, 2006
Federal Register: Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria
 December 19, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance
 December 13, 2006
Federal Register: Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Amendment of Notice
 December 13, 2006
Federal Register: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 December 6, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability; Extension of Comment Period
 November 28, 2006
Federal Register: Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Availability; Extension of Comment Period
 November 28, 2006
Federal Register: Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers; Decorative, Non-Corrective Contact Lenses; Availability
 November 24, 2006
Federal Register: Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting
 November 24, 2006
Federal Register: Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
 November 22, 2006
Federal Register: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 November 17, 2006
Federal Register: Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
 November 15, 2006
Federal Register: Submission for Office of Management and Budget Review; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)
 November 15, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Device User Fee Cover Sheet
November 3, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products
 November 3, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
November 3, 2006
Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 016
 November 3, 2006
Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget; Extension of Expiration Date for MedWatch (Food and Drug Administration Medical Products Reporting Program) Form
 October 26, 2006
Federal Register: Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting
 October 26, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications; Availability
 October 26, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems; Availability
 October 25, 2006
Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget; Extension of Expiration Date for MedWatch (Food and Drug Administration Medical Products Reporting Program) Form
 October 20, 2006
Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 October 20, 2006
Federal Register: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting
 October 20, 2006
Federal Register: Request for Nominations for Voting Members on Public Advisory Panels or Committees
 October 12, 2006
Federal Register: Request for Nominations for Nonvoting Members Representing Industry Intersts on Public Advisory Panels or Committees
October 6, 2006
Federal Register: Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 October 4, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance
 October 3, 2006
Federal Register: Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels
 October 3, 2006
Federal Register: Review of Agreements, Guidances, and Practices Specific to Assignment of Combination Products in Compliance With the Medical Device User Fee and Modernization Act of 2002; Request for Comments
 October 2, 2006
Federal Register: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Draft Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications; Availability
 September 26, 2006
Federal Register: Food and Drug Administration-Regulated Products Containing Nanotechnology Materials; Public Meeting.
 September 26, 2006
Federal Register: Risk Communication on Medical Devices: Sharing Perspectives
 September 8, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability
 September 7, 2006
Federal Register: Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays; Availability
 September 7, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Identifiable
 September 6, 2006
Federal Register: Annual Guidance Agenda
 September 1, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602) (Notice)
 August 29, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397
 August 29, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
 August 24, 2006
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 August 22, 2006
Federal Register: Heparin Catheter Lock-Flush Solutions; Transfer of Primary Responsibility from Center for Drug Evaluation and Research to Center for Devices and Radiological Health
 August 18, 2006
Federal Register: Food and Drug Administration-Regulated Products Containing Nanotechnology Materials; Public Meeting
 August 11, 2006
Federal Register: Unique Device Identification; Request for Comments
 August 11, 2006
Federal Register: Food and Drug Administration Electronic Submissions Gateway
 August 8, 2006
Federal Register: National Mammography Quality Assurance Advisory Committee; Notice of Meeting
August 3, 2006
Federal Register: Medical Device User Fee Rates for Fiscal Year 2007
 August 2, 2006
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems; Availability
 July 27, 2006
Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Fecal Calprotectin Immunological Test Systems
 July 27, 2006
Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 July 25, 2006
Federal Register: Medical Device Regulations; Addresses; Technical Amendment
July 25, 2006
Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 July 25, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey
 July 24, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Need for Online Medical Device Survey
 July 24, 2006
Federal Register: Medical Devices; Anesthesiology Devices; Neurological Devices; Denial of Request for Change in Classification of Breathing Frequency Monitor and Electroencephalograph
 July 14, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet
 June 29, 2006
Federal Register: The Use of Bayesian Statistics in Medical Device Clinical Trials; Public Meeting
 June 29, 2006
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
 June 22, 2006
Federal Register: The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers; Public Workshop
 June 21, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability
 June 20, 2006
Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
June 20, 2006
Federal Register: Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Application Manufacturing Information and Operations; Availability
 June 19, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
 June 7, 2006
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability
June 7, 2006
Federal Register: Medical Devices; Ear, Nose, and Throat Devices; Classification of Olfactory Test Device
 June 7, 2006
Federal Register: Medical Devices; Exception From General Requirements for Informed Consent
 June 7, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
 May 26, 2006
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
 May 26, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials; Availability
 May 23, 2006
Federal Register: Agency Information Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
 May 22, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable
 May 19, 2006
Federal Register: Industry Exchange Workshop to Celebrate Food and Drug Administration Centennial: Past, Present, and Future of Regulated Food, Drugs, Nutritional Supplements, and Medical Devices; Public Workshop
May 3, 2006
Federal Register: Guidance for Industry and Food and Drug Administration Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices; Availability
 May 1, 2006
Federal Register: Guidance for Sponsors, Institutional Review Boards, Clinical Investigators, and FDA Staff; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable; Availability
 April 25, 2006
Federal Register: Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9; Availability.
 April 19, 2006
Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.
 April 19, 2006
Federal Register: Stakeholder Meeting to Discuss the Possible Implementation of Two Review Performance Goals Referenced in the Medical Device User Fee and Modernization Act of 2002; Public Meeting.
April 13, 2006
Federal Register: General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
 April 12, 2006
Federal Register: Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Devices to Detect Influenza A Viruses; Labeling and Regulatory Path; Availability
 April 10, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities - Availability
 April 6, 2006
Federal Register: General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
 April 6, 2006
Federal Register: Joint Meeting of the Dental Products Panel of the Medical Devices Advisory Committee of CDRH and the Peripheral and Central Nervous System Drugs Advisory Committee of CDER
 April 3, 2006
Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 014
 March 31, 2006
Federal Register: Medical Device Reporting; Premarket Approval of Medical Devices; Quality System Regulation; Technical Amendment
 March 31, 2006
Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Reagents for Detection of Specific Novel Influenza A Viruses
 March 29, 2006
Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable
March 29, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting
 March 29, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Health Care Practitioners Regarding Their Preferences for Public Health Notifications
March 29, 2006
Federal Register: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
 March 29, 2006
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Food and Drug Administration Rapid Response Surveys
 March 24, 2006
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Cass II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses; Availability
 March 22, 2006
Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Reagents for Detection of Specific Novel Influenza A Viruses (Final Rule).
 March 22, 2006
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
 March 17, 2006
Federal Register: Immunology and Microbiology Devices; Reclassification of Herpes Simplex Virus (Types 1 and/or 2)Serological Assays; Correction (Proposed Rules; correction).
March 13, 2006
Federal Register: Guidance for Industry and Food and Drug Administration; Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment; Availability
 March 10, 2006
Federal Register: Microbiology Devices; Reclassification of Hepatitis A Virus Serological Assays; Correction.
 March 1, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Availability
 February 15, 2006
Federal Register: Medical Devices; Cardiovascular Devices; Classification of Implantable Intra-Aneurysm Pressure Measurement System
 February 15, 2006
Federal Register: Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
 February 15, 2006
Federal Register: Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System; Availability
 February 15, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Intervertebral Body Fusion Device; Availability.
 February 9, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Pharmacogenetic Test and Genetic Tests for Heritable Markers; Availability.
 February 9, 2006
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Documents; Hepatitis A Virus Serological Assays; Availability.
 February 9, 2006
Federal Register: Microbiology Devices; Reclassification of Hepatitis A Virus Serological Assays.
 February 9, 2006
Federal Register: Medical Device Reporting
 January 10, 2006
Federal Register: Agency Emergency Processing Under Office of Management and Budget Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable
 January 9, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding Their Preferences for Public Health Notifications
 January 9, 2006
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability
 January 9, 2006
Federal Register: Immunology and Microbiology Devices; Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays
 January 9, 2006
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
 January 9, 2006
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mixups at Health Care Facilities--Survey January 3, 2006
  Back to Top